|
Device | ELECSYS FREE PSA IMMUNOASSAY |
Generic Name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P000027 |
Supplement Number | S013 |
Date Received | 11/22/2011 |
Decision Date | 12/21/2011 |
Product Code |
MTG |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO THE INTERMEDIATE STORAGE FORM COATING PROCESS OF THE ELECSYS COATED MICROPARTICLES (BEADS). |